For Immediate Release
Poniard Pharmaceuticals Announces Progression-Free Survival Data From Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer
New Progression-Free Survival, Disease Control and Neurotoxicity Data To Be Presented at 2009 ASCO Annual Meeting Continue to Support Picoplatin as a Neuropathy-Sparing Alternative to Oxaliplatin for First-Line Treatment of Colorectal Cancer
May 28, 2009
South San Francisco, CA -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The new data demonstrated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity in the treatment of first-line metastatic CRC, as assessed by progression-free survival (PFS) and disease control measured by tumor response rate. New data derived by three independent assessments of neurotoxicity indicated a statistically significant reduction in neurotoxicities with the use of picoplatin in FOLPI compared with oxaliplatin in FOLFOX (p<0.0019).
"Oxaliplatin given as part of the FOLFOX-based regimen is the current standard of care for metastatic colorectal cancer, but is associated with severe neuropathy at increasing cumulative doses approaching 800 mg/meter squared. This significant side effect may cause patients extreme pain, numbness and weakness, which is often long-lasting and, in many cases, requires patients to discontinue treatment," said Richard Goldberg, M.D., associate director of clinical research for the University of North Carolina Comprehensive Center and physician-in-chief of the N.C. Cancer Hospital. Dr. Goldberg also is a member of Poniard's Clinical Advisory Board. "I am encouraged that the Phase 2 data continue to suggest that picoplatin is an active platinum agent in patients with advanced colorectal cancer with comparable clinical benefit to oxaliplatin but with significantly less neurotoxicity."
Picoplatin, the Company's lead product candidate, is a new generation platinum-based chemotherapy agent. Clinical studies to date suggest that picoplatin has an improved safety profile. It is in clinical development for multiple indications and combinations and in two formulations. The picoplatin CRC data will be presented at the American Society of Clinical Oncology's 2009 Annual Meeting in Orlando, Fla., during the General Poster Session on Monday, June 1, from 8:00 a.m. to noon Eastern Time (abstract #4026) in W240A, Level 2, with a discussion of the poster scheduled from 11:30 a.m. to 11:45 a.m. in West Hall E1, Level 2.
Phase 2 CRC Trial Design and Updated Results
The randomized, controlled Phase 2 trial is evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who have not received prior chemotherapy. The trial is comparing the safety and efficacy (assessed by objective tumor response, PFS and overall survival) of intravenous picoplatin given once every four weeks in combination with bi-weekly 5-fluorouracil and leucovorin (the FOLPI regimen) with oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen.
The Phase 2 data, scheduled for presentation at the ASCO Annual Meeting, demonstrated that:
-- The median PFS in the intent-to-treat population was 6.8 months for patients randomized and treated with the picoplatin-containing FOLPI regimen compared with 7.0 months for those who received modified FOLFOX-6, containing oxaliplatin.
-- Of the 51 patients in the FOLPI treatment arm, 75 percent achieved disease control (defined as complete response, partial response or stable disease); two patients with a complete response, nine patients with a partial response and 27 patients with stable disease. In the FOLFOX treatment arm of 50 patients, 76 percent achieved disease control; three patients with a complete response, 11 patients with a partial response and 24 patients with stable disease.
-- Only 29 percent of the patients who received FOLPI showed evidence of neurotoxicity compared with 60 percent of patients treated with FOLFOX. In addition, 16 percent of FOLFOX-treated patients exhibited severe (Grade 3/4) neurotoxicity, whereas no FOLPI-treated patients showed evidence of severe neurotoxicity. Three different measurements of neuropathy were statistically significant for FOLPI as a potential neuropathy-sparing alternative to FOLFOX (p<0.0019).
-- With regard to hematologic toxicities, thrombocytopenia and neutropenia were more frequent and severe with the FOLPI regimen compared with FOLFOX. However, only one episode of febrile neutropenia and no bleeding complications have been observed to date. In addition, 83 percent of the planned picoplatin dose of 150 mg/meter squared was able to be delivered monthly in the 51 patients treated in the FOLPI treatment arm of the trial.
-- Nonhematologic adverse events, including gastrointestinal toxicity, were similar between the treatment groups, with the exception of alopecia, which occurred more frequently with FOLPI.
"We continue to be encouraged by these interim, proof-of-concept Phase 2 safety and efficacy results, which suggest the potential of picoplatin in FOLPI as a neuropathy-sparing therapeutic alternative to the use of FOLFOX for the first-line treatment of metastatic colorectal cancer," said Robert De Jager, M.D., chief medical officer of Poniard. "We are continuing to observe the study participants to obtain overall survival data, and expect those data later this year. The new PFS, tumor response and neurotoxicity data provide the rationale to consider additional trials to develop picoplatin as a preferred platinum for the treatment of metastatic colorectal cancer."
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